Abstract
Synopsis
Zidovudine remains the mainstay in the treatment of patients infected with human immunodeficiency virus (HIV). The drug delays disease progression to acquired immunodeficiency syndrome (AIDS) and to AIDS-related complex (ARC), reduces opportunistic infections, and increases survival in patients with advanced HIV infection. There is evidence to suggest that zidovudine also delays disease progression in patients with mild symptomatic disease. Although one study has shown zidovudine to have no significant beneficial effects on survival or disease progression in patients with asymptomatic HIV infection, several other studies have shown zidovudine to delay disease progression in this patient group. Results from related ongoing studies are awaited with interest.
Zidovudine reduces the incidence of AIDS dementia complex (ADC) and appears to prolong survival in these patients, and improves other neurological complications of HIV infection. The drug also appears to enhance the efficacy of Interferon-α in patients with Kaposi’s sarcoma. Although zidovudine is widely used as postexposure prophylaxis following accidental exposure to HIV, its efficacy in preventing seroconversion is unclear. Whether zidovudine prevents vertical transmission also remains to be determined. The overall efficacy of zidovudine in the treatment of children with HIV infection appears similar to that in adults despite more rapid disease progression in younger patients.
Zidovudine-resistant isolates can emerge as early as after 2 months’ therapy, and primary infection with zidovudine-resistant strains has been documented. Both zidovudine resistance and the syncytium-inducing HIV phenotype appear to be associated with poor clinical outcome. However, zidovudine resistance may revert on drug withdrawal or switching to an alternative therapy.
Zidovudine-associated haematotoxicity may be dose-limiting. Nonhaematological adverse events associated with zidovudine therapy are generally mild and usually resolve spontaneously.
Dosages of approximately 500 to 600 mg/day appear to be at least as effective as dosages of 1200 to 1500 mg/day and are better tolerated in patients with less advanced disease. However, optimal dosages are unclear.
Despite beneficial effects, zidovudine monotherapy is not curative. There is evidence to suggest that the concomitant administration of zidovudine with didanosine or zalcitabine is effective in patients with HIV disease progression despite receiving zidovudine monotherapy, and there is some evidence that concomitant zidovudine plus didanosine therapy is more effective than alternating monotherapy. However, results from studies of combination therapy in asymptomatic patients, and from comparative combination therapy studies are awaited. Cotherapy with agents that augment haematopoiesis allows the continuation of therapeutic zidovudine dosages.
Therefore, at present, zidovudine remains the cornerstone in the treatment of HIV infection. In the near future, however, multiple agent zidovudine-containing combination therapy is likely to be the optimal treatment strategy.
Pharmacodynamic Properties
The mechanism of action and in vitro antiviral activity of zidovudine are well established. Zidovudine competitively inhibits viral DNA synthesis and terminates the elongation of viral DNA chains. Synergistic or at least additive in vitro antiviral activity has been observed between zidovudine and a variety of agents with similar (convergent) or different (divergent) mechanisms of action administered in 2 or 3-drug combination regimens. In vitro anti-human immunodeficiency virus (HIV) activity with some combinations has been observed at concentrations below those required with individual agents.
There are in vivo data to suggest that zidovudine may augment cell-mediated immunity and increase the titres of specific virus-neutralising antibodies. Haematopoietic progenitor cells are inhibited by low concentrations of zidovudine, although the molecular basis for zidovudine-induced haematotoxicity is unclear.
Zidovudine-resistant HIV strains can emerge after as few as 2 months’ therapy in patients with initially susceptible HIV isolates, and can occur at all stages of HIV infection. In fact, primary infection with zidovudine-resistant strains has recently been reported. Multiple mutations in the HIV pol gene are associated with the emergence of zidovudine resistance, and patients may harbour several viral strains. Longer duration of therapy, more advanced disease, lower pretreatment CD4+ cell counts and HIV antigenaemia increase the likelihood of developing drug resistance. Highly resistant strains appear to emerge more frequently in patients with advanced rather than early disease, and resistance tends to develop earlier with zidovudine dosages of 1200 to 1500 mg/day than dosages of approximately 500 mg/day.
Both zidovudine resistance and the syncytium-inducing HIV phenotype appear to be correlated with poor clinical outcome. Cross-resistance between zidovudine and compounds containing a 3′-azido group has been reported, and a low level of cross resistance to didanosine, zalcitabine and nevirapine has been observed. Zidovudine susceptibility may return following drug withdrawal or switching to an alternative agent. The effect of zidovudine-containing combination therapy on the development of zidovudine resistance and on the replication of zidovudine-resistant HIV strains is not clear, although the convergent approach has the potential to delay multidrug resistance.
Pharmacokinetic Properties
There is an approximately linear relationship between single and multiple zidovudine doses and peak plasma zidovudine concentration (Cmax). However, there is little correlation between plasma zidovudine concentrations, intracellular total phosphorylated zidovudine concentrations (zidovudine triphosphate is the active form) and zidovudine dosage. The mean terminal phase elimination half-life (t½) of total phosphorylated zidovudine approximates that of zidovudine triphosphate in vitro and is 2 to 3 times that of plasma zidovudine. This supports the use of regimens with relatively long dosage intervals and low dosages.
The oral bioavailability of zidovudine is approximately 60% and the time to Cmax (tmax) occurs after 0.5 to 1.5h in most patients. High-fat meals decrease zidovudine area under the concentration-time curve (AUC), delay tmax and decrease Cmax, whereas liquid-based protein meals do not affect zidovudine absorption.
Zidovudine is highly lipophilic and is widely distributed. The drug concentrates in the semen and crosses the placenta. HIV has been isolated from breast milk although the risk of vertical transmission via breastfeeding is not clear, and there have been no data published on the penetration of zidovudine into human breast milk. The drug penetrates into the cerebrospinal fluid (CSF) with zidovudine CSF: plasma ratios ranging from less than 0.1 to 2.05 in patients with acquired immunodeficiency syndrome (AIDS) or AIDS-related complex (ARC). Delivery systems to facilitate the penetration of zidovudine into the central nervous system have been investigated.
Zidovudine is extensively and primarily metabolised by the liver to 3 metabolites, one of which, zidovudine glucuronide (GZDV), is active while the contribution of the other 2 to the pharmacological effects of zidovudine is unknown.
There is high interpatient variability in the pharmacokinetics of zidovudine. The pharmacokinetics of zidovudine in children are similar but more variable than in adults, whereas zidovudine clearance is markedly reduced and the t½ of zidovudine and its glucuronide are prolonged in neonates. Zidovudine t½ is increased in the elderly. The pharmacokinetic profile of zidovudine in patients with asymptomatic HIV infection, advanced HIV infection and in healthy volunteers appears similar. Decreases in AUC and increases in clearance during pregnancy compared with the postpartum period may be explained by the physiology of pregnancy. A trend towards decreased presystemic elimination, probably as a result of delayed glucuronidation, has been observed in patients with hepatic impairment. Zidovudine clearance appears lower in patients with haemophilia. Accumulation of GZDV may occur in patients with renal impairment.
Therapeutic Efficacy
The efficacy of zidovudine as a first-line agent in the treatment of patients with advanced HIV infection (AIDS or ARC) is well established; zidovudine increases survival rates for up to 3 years, decreases opportunistic infections, and delays the progression of ARC to AIDS. Maximal survival benefits occur with the concomitant use of Pneumocystis carinii pneumonia prophylaxis in patients with CD4+ counts <200 cells/μl.
Limited data suggest that zidovudine may delay disease progression to ARC, AIDS or death in patients with mildly symptomatic HIV infection and CD4+ counts <500 cells/μl and there is some evidence that ‘early’ (CD4+ counts between 200 and 500 cells/μl) treatment is more effective than ‘late’ (CD4+ counts <200 cells/μl) treatment in delaying disease progression and increasing the time to subsequent CD4+ cell count decline. However, there is ongoing debate about the optimal time to initiate zidovudine therapy in asymptomatic patients. The long term effects and survival benefits of early administration of zidovudine are not known.
Dosages of approximately 600 mg/day appear to be at least as effective as dosages of 1200 to 1500 mg/day in patients with advanced HIV infection, in terms of survival rates, disease progression, CD4+ cell counts and well-being. However, optimal zidovudine dosages in different patient groups, and the effects of zidovudine dosages of 500 to 600 mg/day on neurological complications and malignancies associated with HIV are unknown.
Zidovudine reduces the incidence of AIDS dementia complex ADC and improves other neurological manifestations of HIV infection, and appears to prolong survival in patients with ADC although the long term effects of the drug in these conditions are not known. The drug appears to enhance the efficacy of interferon-α in patients with Kaposi’s sarcoma. Zidovudine is widely used as postexposure prophylaxis following accidental exposure to HIV although its efficacy in preventing seroconversion is unclear. Data on the use of zidovudine in pregnancy are scarce and whether zidovudine prevents vertical transmission remains unknown. The overall efficacy of zidovudine in the treatment of children with HIV infection appears similar to that in adults despite more rapid disease progression in younger patients.
Convergent and divergent combination therapy regimens have been studied in an attempt to increase zidovudine efficacy and consequently reduce zidovudine dosage requirements, reduce the development of resistance and tcxicity, and preserve immunological function. The concomitant administration of zidovudine with didanosine or zalcitabine appears effective in patients with disease progression despite receiving zidovudine monotherapy. Although the efficacy of zidovudine in alternating regimens with other nucleosides has been documented, the benefits of alternating therapy over intermittent or continuous administration of the individual agents are not clear. The concomitant administration of zidovudine and didanosine appears to be more effective than alternating therapy with the individual agents. Some patients may benefit from a switch in therapy from zidovudine monotherapy to didanosine monotherapy but the optimal time of switching therapy is not known. Several other agents have shown promise in combination with zidovudine, and results from studies of combination therapy in asymptomatic patients, multiple agent studies and comparative combination therapy studies are awaited.
Tolerability
Dose-limiting anaemia and neutropenia are the most serious and frequently occurring adverse effects associated with zidovudine therapy. However, dosages of 500 to 600 mg/day are associated with fewer adverse haematological effects, patient withdrawals and dosage adjustments than dosages of approximately 1500 mg/day, and are associated with a longer time to a first dosage adjustment. In terms of haematotoxicity, intermittent zidovudine therapy appears better tolerated than continuous therapy. Frequent monitoring of full blood counts are required in all zidovudine recipients.
Nonhaematological adverse events associated with zidovudine therapy are generally mild and usually resolve spontaneously. Headache, myalgia and insomnia occur more frequently in patients with advanced HIV infection whereas vomiting, anorexia, malaise and asthenia appear to occur more commonly in patients with earlier disease. Associations between zidovudine and nail, skin and mucosal hyperpigmentation and myopathy have been reported.
In reducing zidovudine-associated toxicity, combination therapy is an alternative strategy to dosage adjustment and drug withdrawal. Cotherapy with zidovudine and agents that augment haematopoiesis reduces, ameliorates or prevents zidovudine-associated neutropenia and anaemia, and allows full dosages of zidovudine to be continued. Although combination therapy with zidovudine and agents that have synergistic antiviral effects appear to be generally well tolerated, long term toxicity remains to be determined.
Drug Interactions
There is evidence that the coadministration of zidovudine with didanosine may result in increased plasma zidovudine concentrations. No significant plasma pharmacokinetic drug interactions between zidovudine and zalcitabine, granulocyte-macrophage colony-stimulating factor (GM-CSF), aciclovir, foscarnet, or antituberculosis agents have been reported.
Caution is recommended when zidovudine is administered with agents known to inhibit its glucuronidation including probenecid, valproic acid, naproxen, indomethacin and oxazepam.
Drugs secreted by the organic base transport system in the kidney (e.g. trimethoprim and cimetidine) may reduce renal clearance of zidovudine. Methadone may increase serum zidovudine concentrations, and spontaneous increases or decreases in phenytoin concentrations in zidovudine recipients have been reported.
Dosage and Administration
Optimal dosage regimens for zidovudine with and without other agents in HIV infection are still evolving. The drug may be initiated at dosages as low as 500 mg/day in patients with asymptomatic disease. A dosage of 1000 mg/day in 4 or 5 divided doses is currently recommended by the manufacturer in patients with symptomatic disease, although many patients with symptomatic disease have received zidovudine dosages of 500 to 600 mg/day in clinical trials. The recommended starting dosage in children more than 3 months of age is 180 mg/m2 every 6 hours. Dosage adjustments appear necessary in patients with hepatic impairment although precise recommendations have not been made. Caution is also recommended when the drug is administered to patients with renal impairment and to the elderly. Dosage adjustments appear unnecessary in patients undergoing dialysis.
Dosage reduction or interruption may be required in patients with zidovudine-induced haematotoxicity. Alternatively, concomitant or alternating regimens with other agents may allow the continuation of therapeutic dosages of zidovudine or a reduction in the required dosage. The drug is not recommended in patients with severe baseline neutropenia or anaemia. Concurrent use of potentially myelosuppressive, cytotoxic or nephrotoxic agents with zidovudine is not advised. Agents that interfere with the metabolism or renal excretion of zidovudine should be used with caution.
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Various sections of the manuscript reviewed by: A.B. Boucher, Antiviral Therapy Laboratory, Department of Virology, Academic Medical Center, Amsterdam, The Netherlands; E. Buira, Infectious Disease Unit, Hospital Clinic, Faculty of Medicine, Barcelona, Spain; N.M.H. Graham, Department of Epidemiology, Johns Hopkins University School of Hygiene and Public Health, Baltimore, Maryland, USA; J.D. Hamilton, Veterans Affairs Medical Center, Durham, North Carolina, USA; S. Kimura, Department of Infectious Diseases, Institute of Medical Science, University of Tokyo, Tokyo, Japan; S.E. Krown, Memorial Sloan-Kettering Cancer Center, New York, New York, USA; J. Mallolas, Infectious Disease Unit, Hospital Clinic, Faculty of Medicine, Barcelona, Spain; R.E. McKinney, Duke University Medical Center, Durham, North Carolina, USA; T-C. Meng, University of California, San Diego Treatment Center, Departments of Medicine & Pediatrics, San Diego, California, USA; A.J. Pinching, Department of Immunology, Medical College of Saint Bartholomew’s Hospital, London, England; E. Singlas, Clinical Pharmacy, Necker-Enfants Malades, Paris, France; B. Stretcher, Department of Pathology and Laboratory Medicine, University of Cincinnati Hospital, Cincinnati, Ohio, USA; S. Vella, Laboratory of Virology, Istituto Superiore di Sanità, Rome, Italy; P.A. Volberding, San Francisco General Hospital, San Francisco, California, USA; I.G. Williams, University College London Medical School, Academic Department of Genito-Urinary Medicine, London, England; R. Yarchoan, National Institutes of Health, Bethesda, Maryland, USA.
An erratum to this article is available at http://dx.doi.org/10.1007/BF03259112.
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Wilde, M.I., Langtry, H.D. Zidovudine. Drugs 46, 515–578 (1993). https://doi.org/10.2165/00003495-199346030-00010
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DOI: https://doi.org/10.2165/00003495-199346030-00010